FLUDEOXYGLUCOSE F18 Solution for injection Ref.[11029] Active ingredients: Fludeoxyglucose ¹⁸F

5.1 Radiation Risks

Radiation-emitting products, including Fludeoxyglucose F18 Injection USP, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration (2.5)].

5.2 Blood Glucose Abnormalities

In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. In these patients, consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to Fludeoxyglucose F18 Injection administration.

Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting. Have emergency resuscitation equipment and personnel immediately available.

The interaction of Fludeoxyglucose F18 Injection USP with other drugs taken by patients undergoing PET imaging has not been studied.

Risk Summary

Data from published case series and case reports describe Fludeoxyglucose F18 Injection crossing the placenta with uptake by the fetus (see Data). All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. However, published studies that describe Fludeoxyglucose F18 Injection use in pregnant women have not identified a risk of drug-associated major birth defects, miscarriage, or adverse maternal or fetal outcomes. If considering Fludeoxyglucose F18 Injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Fludeoxyglucose F18 Injection and the gestational timing of exposure.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.

Data

Human Data

Data from published case series and case reports describe Fludeoxyglucose F18 Injection crossing the placental barrier and visualization of radioactivity throughout the body of the fetus. The estimated fetal absorbed radiation dose from the maximum labeled dose (370 MBq) of Fludeoxyglucose F18 was 10mGy with first trimester exposure to PET alone and 20mGy with first trimester exposure to PET/CT scan combination. Long-term adverse radiation effects to a child exposed to Fludeoyxglucose F18 Injection in utero are unknown. No adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50mGy, which represents less than 20mGy fetal doses.

Risk Summary

A published case report and case series show the presence of Fludeoxyglucose F18 Injection in human milk following administration. There are no data on the effects of Fludeoxyglucose F18 Injection on the breastfed infant or the effects on milk production. Exposure of Fludeoxyglucose F18 Injection to a breastfed infant can be minimized by temporary discontinuation of breastfeeding (see Clinical Considerations). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Fludeoxyglucose F18 Injection, any potential adverse effects on the breastfed child from Fludeoxyglucose F18 Injection or from the underlying maternal condition.

Clinical Considerations

To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breastmilk and avoid close (breast) contact with the infant for at least 9 hours after the administration of Fludeoxyglucose F18 Injection.

The safety and effectiveness of Fludeoxyglucose F18 Injection in pediatric patients with epilepsy is established on the basis of studies in adult and pediatric patients. In pediatric patients with epilepsy, the recommended dose is 2.6 mCi. The optimal dose adjustment on the basis of body size or weight has not been determined.

In the oncology or cardiology settings, the safety and effectiveness of Fludeoxyglucose F18 Injection have not been established in pediatric patients.